Domain | Data source | Measures – Instrument (Scale – high value is better score unless specified) | Time points |
---|---|---|---|
Function | Research Clinic Questionnaire (participant reported) | Michigan Hand Outcomes Questionnaire (MHQ)– overall Hand function score (0–100) | 0, 4, 12 |
 |  | Michigan Hand Outcomes Questionnaire (MHQ)– overall score (0–100) |  |
Pain | Research Clinic Questionnaire | Pain sub-scale of MHQ (0–100; high score is worse) | 0, 4, 12 |
 |  | ‘Troublesomeness’ rating (0–20; high score is worse) |  |
Impairment | Research Clinic Examination (performed by outcome assessor) | Joint deformity (MCPJ only) – goniometer (Degrees; high score is worse) | 0, 4, 12 |
 |  | Wrist range of motion (flexion/extension) – goniometer (Degrees) |  |
 |  | Finger range of motion (combined flexion and combined extension) – Ruler (mm; high score is worse for combined flexion) |  |
 |  | Thumb opposition range of motion - observation (0–10) |  |
 |  | Dexterity - timed 9 hole peg test (Seconds; high score is worse) |  |
 |  | Grip and Pinch Strength – dynamometer (Newtons) |  |
Disease Activity | Medical Records Research Clinic Examination | Erythrocyte sedimentation rate (ESR – mm/h) and/or C-Reactive protein (CRP – mg/l) blood test | 0, 4, 12 |
 |  | Hand and wrist joint tenderness and swelling count – examination (0–22; high score is worse) |  |
Health-related Quality of Life | Research Clinic Questionnaire | SF-12(0-100) | 0, 4, 12 |
 |  | EuroQol EQ-5D (health utility)(0–1) |  |
Self-efficacy | Research Clinic Questionnaire | 7 item questionnaire | 0, 4, 12 |
Satisfaction | Research Clinic Questionnaire | Treatment satisfaction item | 4,12 |
 |  | Satisfaction sub-scale of MHQ (0–100) |  |
Global Change | Research Clinic Questionnaire | Participant-rated global change question(7 point Likert scale) | 4, 12 |
Adherence | Research Clinic Questionnaire | 5 item questionnaire | 0, 4, 12 |
Economics | Research Clinic Questionnaire | Resource use questionnaire | 4, 12 |